(21 days)
The TranQuill barbed device comprised of polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The TranQuill barbed device is a sterile, synthetic absorbable device that is intended for use in the approximation of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The device is designed with small bi-directional barbs along the long axis of the suture monofilament. It is available in diameter Size 0 through 2-0 in various lengths affixed to various needle types.
The provided text describes a 510(k) premarket notification for a medical device called the TranQuill barbed device, an absorbable surgical suture. The focus of the documentation is to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|---|
| Material Composition | Comprised of Polydioxanone (PDO) | Comprised of Polydioxanone (PDO), dyed with D&C Violet No. 2 |
| Design | Designed with small bi-directional barbs along the long axis of the suture monofilament | Designed with small bi-directional barbs along the long axis of the suture monofilament |
| Physical Dimensions | Available in diameter Size 0 through 2-0 in various lengths | Available in diameter Size 0 through 2-0 in various lengths |
| Sterility | Sterile | Sterile |
| Tensile Strength | Conforms to USP monograph for absorbable sutures | Conforms to USP monograph for absorbable sutures |
| In vitro Barb Holding Strength | Performance comparable to predicate device | Demonstrated substantial equivalence to predicate device in barb holding strength |
| Post-Hydrolysis Tensile Testing | Performance comparable to predicate device | Demonstrated substantial equivalence to predicate device in post-hydrolysis tensile strength |
| Intended Use | Soft tissue approximation where use of absorbable sutures is appropriate | Indicated for soft tissue approximation where use of absorbable sutures is appropriate |
| Biocompatibility | Not explicitly stated as a test, but implied by regulatory requirements for implantable materials | Not explicitly stated, but implied by use of PDO, a known biocompatible material |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The documentation mentions "Non-clinical laboratory performance testing," but does not provide specific sample numbers for each test (e.g., number of sutures tested for tensile strength).
- Data Provenance: The testing was "Non-clinical laboratory performance testing," indicating it was conducted in a controlled lab environment. There is no information about the country of origin of the data or whether it was retrospective or prospective, as it pertains to benchtop testing rather than clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This device is a surgical suture, and the evaluation focused on non-clinical laboratory performance testing to establish substantial equivalence to a predicate device. It did not involve a test set requiring expert interpretation or ground truth establishment in the context of diagnostic or screening performance.
4. Adjudication Method for the Test Set:
- Not applicable. As the study involved non-clinical laboratory performance testing of physical characteristics, there was no need for an adjudication method as would be used in studies involving subjective expert opinions or diagnostic interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is typically performed for diagnostic or screening devices to assess human reader performance with and without AI assistance. The TranQuill device is a surgical product, not a diagnostic tool requiring interpretation by multiple readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Not applicable. The device is a physical surgical suture, not a software algorithm. Therefore, there is no "standalone performance" in the context of an algorithm.
7. Type of Ground Truth Used:
- Objective Measurement and Standards Compliance: The "ground truth" for this evaluation was based on objective measurements and adherence to established standards and predicate device performance.
- USP monograph for absorbable sutures: This serves as a "ground truth" or standard for tensile strength.
- Predicate device characteristics: The performance of the predicate device (Quill Synthetic Absorbable Barbed Suture, Quill™ Self-Retaining System (SRS) comprised of PDO) served as the comparative "ground truth" for barb holding strength and post-hydrolysis tensile testing.
8. Sample Size for the Training Set:
- Not applicable. This device is a physical medical device (suture), not an AI/ML algorithm that requires a training set. The evaluation focuses on physical and mechanical properties.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for a physical device, this question is not relevant.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.